US20150190242A1 - Expandable interbody device - Google Patents

Abstract

An expandable interbody device for placement between adjacent vertebrae having an upper structure, a lower structure and a screw mechanism, wherein actuation of the screw mechanism moves the upper and lower structures between a collapsed configuration and an expanded configuration. A deployment tool couples to the expandable interbody device for positioning the device between adjacent vertebrae, actuating the screw mechanism and delivering a material to a chamber of the expandable interbody device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57, including U.S. Provisional Application Nos. 61/912,360, filed Dec. 5, 2013 and 61/912,432, filed Dec. 5, 2013.
BACKGROUND
• 1. Field
• The present disclosure generally relates to the field of spinal orthopedics, and more particularly to expandable spinal implants for placement in intervertebral spaces between adjacent vertebrae.
• 2. Related Art
• The spine is a flexible structure that extends from the base of the skull to the tailbone. The weight of the upper body is transferred through the spine to the hips and the legs. The spine contains a plurality of bones called vertebrae. The vertebrae are hollow and stacked one upon the other, forming a strong hollow column for support. The hollow core of the spine houses and protects the nerves of the spinal cord. The spine is held upright through the work of the back muscles, which are attached to the vertebrae. While the normal spine has no side-to-side curve, it does have a series of front-to-back curves, giving it a gentle “S” shape.
• Each vertebra is separated from the vertebra above or below by a cushion-like, fibrocartilage called an intervertebral disc. The discs act as shock absorbers, cushioning the spine, and preventing individual bones from contacting each other. In addition, intervertebral discs act as a ligament that holds vertebrae together. Intervertebral discs also work with the facet joint to allow for slight movement of the spine. Together, these structures allow the spine to bend, rotate and/or twist.
• The spinal structure can become damaged as a result of degeneration, dysfunction, disease and/or trauma. More specifically, the spine may exhibit disc collapse, abnormal curvature, asymmetrical disc space collapse, abnormal alignment of the vertebrae and/or general deformity, which may lead to imbalance and tilt in the vertebrae. This may result in nerve compression, disability and overall instability and pain. If the proper shaping and/or curvature are not present due to scoliosis, neuromuscular disease, cerebral palsy, or other disorder, it may be necessary to straighten or adjust the spine into a proper curvature with surgery to correct these spinal disorders.
• Surgical treatments may involve manipulation of the spinal column by attaching a corrective device, such as rods, wires, hooks or screws, to straighten abnormal curvatures, appropriately align vertebrae of the spinal column and/or reduce further rotation of the spinal column. The correct curvature is obtained by manipulating the vertebrae into their proper position and securing that position with a rigid system of screws and rods. The screws may be inserted into the pedicles of the vertebrae to act as bone anchors, and the rods may be inserted into heads of the screws. Two rods may run substantially parallel to the spine and secure the spine in the desired shape and curvature. Thus the rods, which are shaped to mimic the correct spinal curvature, force the spine into proper alignment. Bone grafts are then placed between the vertebrae and aid in fusion of the individual vertebrae together to form a correctly aligned spine.
• Other ailments of the spine result in degeneration of the spinal disc in the intervertebral space between adjacent vertebrae. Disc degeneration can cause pain and other complications. Conservative treatment can include non-operative treatment requiring patients to adjust their lifestyles and submit to pain relievers and a level of underlying pain. Operative treatment options include disc removal. This can relieve pain in the short term, but also often increases the risk of long-term problems and can result in motor and sensory deficiencies resulting from the surgery. Disc removal and more generally disc degeneration disease are likely to lead to a need for surgical treatment in subsequent years. The fusion or fixation will minimize or substantially eliminate relative motion between the fixed or fused vertebrae. In surgical treatments, interbody implants may be used to correct disc space collapse between adjacent vertebra, resulting in spinal fusion of the adjacent vertebra.
• A fusion is a surgical method wherein two or more vertebrae are joined together (fused) by way of interbody implants, sometimes with bone grafting, to form a single bone. The current standard of care for interbody fusion requires surgical removal of all or a portion of the intervertebral disc. After removal of the intervertebral disc, the interbody implant is implanted in the interspace. In many cases, the fusion is augmented by a process called fixation. Fixation refers to the placement of screws, rods, plates, or cages to stabilize the vertebrae so that fusion can be achieved.
• Interbody implants must be inserted into the intervertebral space in the same dimensions as desired to occupy the intervertebral space after the disc is removed. This requires that an opening sufficient to allow the interbody implant must be created through surrounding tissue to permit the interbody implant to be inserted into the intervertebral space. In some cases, the intervertebral space may collapse prior to insertion of the interbody implant. In these cases, additional hardware may be required to increase the intervertebral space prior to insertion of the implant.
• In addition, minimally invasive surgical techniques have been used on the spine. Under minimally invasive techniques, access to the intervertebral space is taken to reach the spine through small incisions. Through these incisions, discs are removed and an interbody implant is placed in the intervertebral disc space to restore normal disc height. Minimally invasive spine surgery offers multiple advantages as compared to open surgery. Advantages include: minimal tissue damage, minimal blood loss, smaller incisions and scars, minimal post-operative discomfort, and relative quick recovery time and return to normal function.
SUMMARY
• It would be desirable to insert an interbody device with a first smaller dimension into an intervertebral space and once in place, deploy to a second, relatively larger dimension to occupy the intervertebral space. This first smaller dimension can permit the use of minimally invasive surgical techniques for easy access to the intervertebral space, which can cause less disruption of soft and boney tissue in order to get to the intervertebral space. The interbody device may be implanted with or without the need of additional hardware.
• Disclosed is an expandable interbody device that is configured to have an initial collapsed configuration having a first height suitable for being inserted into an intervertebral space between a pair of adjacent vertebrae, and an expanded configuration having a second height that is greater than the first height. The implant can be expanded from the initial collapsed configuration to the expanded configuration in-situ. The expanded configuration can provide support to the adjacent vertebrae while bone fusion occurs and can also provide rigid support between the adjacent vertebrae that withstands compressive forces. In some configurations, the expandable interbody device can help increase the distance between the adjacent vertebrae. By inserting the expandable interbody device in the initial collapsed configuration into the intervertebral space, it is possible to perform the surgery percutaneously with minimal disruption to tissues surrounding the surgical site and intervening soft tissue structures. The expandable interbody device can be implanted through a minimally invasive or an open wound procedure.
• In accordance with at least one of the embodiments disclosed herein, an expandable interbody device for placement between adjacent vertebrae can comprise an upper structure comprising an upper proximal angled surface and an upper distal angled surface; a lower structure comprising a lower proximal angled surface and a lower distal angled surface, the lower structure configured to slideably couple with the upper structure; and a screw mechanism between the upper structure and the lower structure. The screw mechanism can comprise a proximal section comprising a proximal frustoconical surface, a distal section comprising a distal frustoconical surface, and a coupler comprising a proximal side configured to engage the proximal section and a distal side configured to engage the distal section, wherein the proximal section and the distal section are configured to rotate as a unit to change a length of the screw mechanism from a first length to a second length. The proximal frustoconical surface can be configured to engage the upper proximal angled surface and the lower proximal angled surface, and the distal frustoconical surface can be configured to engage the upper distal angled surface and the lower distal angled surface to move the upper structure and the lower structure from a first distance to a second distance.
• The coupler can further comprise at least one anti-rotational feature configured to engage the upper structure or lower structure to prevent the coupler from rotating when the proximal section and the distal section are rotated.
• The proximal section can comprise first threads wound in a first direction configured to engage a proximal threaded hole in the coupler, and the distal section can comprise second threads wound in a second direction, opposite the first direction, configured to engage a distal threaded hole in the coupler. In some embodiments, the first threads and the second threads have an equal pitch, such that when the screw mechanism is actuated, a proximal end of the interbody device changes height at the same rate as a distal end of the interbody device. In other embodiments, the first threads and the second threads have a different pitch, such that when the screw mechanism is actuated, a proximal end of the interbody device changes height at a different rate than a distal end of the interbody device.
• The upper structure and lower structure can further comprise a plurality of protrusions or teeth. The upper structure and/or the lower structure can comprise vertebrae engagement surfaces with a porous or roughened surface. For example, the vertebrae engagement surfaces can comprise a titanium coating.
• In some embodiments, the proximal section comprises at least one hole in fluid communication with a drive interface and an interior cavity of the interbody device. The interbody device can further comprise at least one recess configured to couple with a deployment tool, the at least one recess comprising a hole in fluid communication with an interior cavity of the interbody device.
• In some embodiments, the distal section comprises a keyed shaft configured to slideably engage with a matching keyed bore on the proximal section.
• In accordance with at least one of the embodiments disclosed herein, an expandable interbody device for placement between adjacent vertebrae can comprise an upper structure, a lower structure configured to slideably couple with the upper structure, and a screw mechanism between the upper structure and the lower structure, the screw mechanism comprising a proximal section and a distal section that are configured to rotate as a unit to change a length of the screw mechanism from a first length to a second length, wherein the change in the length of the screw mechanism causes the distance between the upper structure and the lower structure to change from a first distance to a second distance to form a chamber to be filled by one or more of fluids, medication, bone graft material, allograft and Demineralized Bone Matrix.
• In accordance with at least one of the embodiments disclosed herein, a kit for performing spinal stabilization can comprise an expandable interbody device for placement between adjacent vertebrae, wherein in an expanded configuration the expandable interbody device comprises a chamber, and a deployment tool for delivering the expandable interbody device between adjacent vertebrae, the deployment tool comprising a distal portion that is releasably attachable to the expandable interbody device and a proximal portion configured to extend outside a surgical incision. The proximal portion can comprise an opening to a channel that extends through the deployment tool and is in fluid communication with the distal portion of the deployment tool, the channel capable of transporting a material from outside the incision into the chamber of the expandable interbody device.
• In some embodiments, a proximal section of the expandable interbody device comprises at least one hole in fluid communication with the chamber. The expandable interbody device can further comprise at least one recess with a hole that is in fluid communication with the chamber. The deployment tool can comprise arms that are configured to attach to the at least one recess and further comprise one or more channels extending to the tips of the arms to deliver material through the at least one recess into the chamber of the expandable interbody device.
• In accordance with at least one of the embodiments disclosed herein, a method of implanting an expandable interbody device between adjacent vertebrae can comprise positioning the expandable interbody device between adjacent vertebrae. The expandable interbody device can comprise an upper structure, a lower structure configured to slideably couple with the upper structure, and a screw mechanism between the upper structure and the lower structure. The method can further comprise rotating the screw mechanism to change a length of the screw mechanism from a first length to a second length which causes the distance between the upper structure and the lower structure to change from a first distance to a second distance to form a chamber, and injecting material into the chamber.
• In some embodiments, the first distance corresponds to a collapsed configuration with the upper structure adjacent the lower structure and the second distance corresponds to an expanded configuration with the upper structure separated from the lower structure.
• The screw mechanism can comprise a proximal section comprising a proximal frustoconical surface, a distal section comprising a distal frustoconical surface, and a coupler comprising a proximal side configured to engage the proximal section and a distal side configured to engage the distal section.
• The material can be one or more of fluids, medication, bone graft material, allograft and Demineralized Bone Matrix.
• In some embodiments, the expandable interbody device can be positioned between the adjacent vertebrae using a deployment tool that extends from the vertebrae to outside an incision.
• The step of injecting the material can comprise delivering the material through a channel extending through the deployment tool.
• In accordance with at least one of the embodiments disclosed herein, an expandable interbody device for placement between adjacent vertebrae can comprise an outer structure having a central opening and front and back sides with opposed front and back openings, an inner structure configured to slideably fit vertically within the outer structure central opening, the inner structure having a central opening and front and back sides with opposed front and back threaded holes axially aligned with the opposed front and back openings of the outer structure, and a variable length screw mechanism having proximal and distal heads slideably engaged to the front and back openings of the outer structure, and proximal and distal threaded shafts threadably coupled to the front and back threaded holes of the inner structure, wherein rotation of the screw mechanism changes a length of the screw mechanism from a first length to a second length and the proximal and distal heads compress against the front and back openings resulting in vertical translation of the inner structure relative to the outer structure from a first height to a second height.
• The first height can be a collapsed configuration with the inner structure within the outer structure central opening and the second height can be an expanded configuration with the inner structure extending vertically out of the outer structure central opening.
• The threaded shafts can comprise proximal threads threadably coupled to the front threaded hole with first threads in a first direction, and distal threads threadably coupled to the back threaded hole with second threads in a second direction, opposite the first direction, such that when the screw mechanism is rotated, the length of the screw mechanism increases or decreases. In some embodiments, the first and second threads have an equal pitch, such that when the screw mechanism is rotated the vertical translation of a proximal end and a distal end of the inner structure moves at a same rate relative to a proximal end and a distal end of the outer structure. In other embodiments, the first and second threads have a different pitch, such that when the screw mechanism is rotated the vertical translation of a proximal end of the inner structure relative to the outer structure moves at a different rate than a distal end of the inner structure relative to the outer structure.
• In some embodiments, the front and back openings of the outer structure comprise ramp portions and the proximal and distal heads of the variable length screw mechanism can be configured to engage and slide along the ramp portions during translation of the inner structure relative to the outer structure. In other embodiments, the front and back openings of the outer structure have non-complementary engagement surfaces with the proximal and distal heads of the variable length screw mechanism, and the proximal and distal heads of the variable length screw mechanism are configured to engage and slide along the non-complementary engagement surfaces during translation of the inner structure relative to the outer structure.
• The interbody device can further comprise a keyed internal bore on the distal end of the proximal shaft, and a keyed outer surface on the proximal end of the distal shaft configured to slidingly engage with the keyed internal bore of the proximal shaft, wherein the keyed outer surface slides within the keyed internal bore to allow the screw mechanism to have a variable length. The outer structure and inner structure can further comprise a plurality of protrusions or teeth.
• In some embodiments, the vertebrae engagement surfaces comprise a porous or roughened surface that may be formed of a porous material, coated with a porous material, or chemically etched to form a porous or roughened surface with pores for bone growth with the adjacent vertebra.
• In accordance with at least one of the embodiments disclosed herein, an expandable interbody device for placement between adjacent vertebrae can comprise an outer structure having an outer wall enclosing a central opening, the outer wall having front and back sides with opposed front and back openings, an inner structure having an inner wall with a lower flanged portion enclosing a central opening, the inner wall being configured to slideably fit vertically within the outer structure central opening, the inner wall having front and back slots with ramps proximate the slots within the inner structure central opening, the front and back slots being axially aligned with the opposed front and back openings of the outer structure, and a screw mechanism coupled to the inner and outer structures. The screw mechanism can comprise a shaft with proximal and distal portions, and proximal and distal threaded ramped components threadably coupled to the proximal and distal portions, the ramped components being configured to slideably engage the ramps on the front and back sides of the inner structure during expansion of the screw mechanism. Rotation of the expansion screw mechanism can change a distance between the proximal and distal ramped components from a first length to a second length and the proximal and distal ramped components slide against the front and back ramps resulting in vertical translation of the inner structure relative to the outer structure from a first height to a second height.
• The proximal and distal portions of the shaft can comprise proximal and distal ends positioned within the front and back openings of the outer structure. A proximal end of the shaft can comprise a tool engagement portion.
• The shaft can comprise proximal threads threadably coupled to the proximal threaded ramped component with first threads in a first direction, and distal threads threadably coupled to the distal threaded ramped component with second threads in a second direction, opposite the first direction, such that when the screw mechanism is rotated, the distance between the proximal and distal ramped components increases or decreases.
• In some embodiments, the first and second threads have an equal pitch, such that when the screw mechanism is rotated the vertical translation of a proximal end and a distal end of the inner structure moves at a same rate relative to a proximal end and a distal end of the outer structure. In other embodiments, the first and second threads have different pitches, such that when the screw mechanism is rotated the vertical translation of a proximal end of the inner structure relative to the outer structure moves at a different rate than a distal end of the inner structure relative to the outer structure.
• The outer structure and inner structure can further comprise a plurality of protrusions or teeth. The vertebrae engagement surfaces can comprise a porous or roughened surface that may be formed of a porous material, coated with a porous material, or chemically etched to form a porous or roughened surface with pores for bone growth with the adjacent vertebra.
• In accordance with at least one of the embodiments disclosed herein, a deployment tool for delivering an expandable interbody device between adjacent vertebrae can comprise a distal portion configured to releasably couple to the expandable interbody device, a proximal portion comprising a mechanism for coupling and releasing the expandable interbody device, and an actuation device capable of expanding the interbody device from a first configuration to a second configuration, wherein the proximal portion is configured to extend outside a surgical incision, wherein the proximal portion comprises an opening to a channel that extends through the deployment tool and is in fluid communication with the distal portion of the deployment tool, the channel capable of transporting a material from outside the incision into the expandable interbody device.
• The distal portion can comprise arms configured to couple to at least one recess on the expandable interbody device. The arms can comprise one or more channels extending to the tips of the arms to deliver material through the at least one recess into a chamber of the expandable interbody device. The actuation device can comprise a shaft that extends through the deployment tool to drive the expandable interbody device at the distal portion by manipulating an actuator at the proximal portion.
BRIEF DESCRIPTION OF THE DRAWINGS
• Specific embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
• FIG. 1 is a perspective view showing an expandable interbody device in a collapsed configuration, according to an embodiment of the present invention.
• FIG. 2 is a perspective view showing the expandable interbody device ofFIG. 1 in an expanded configuration.
• FIG. 3 is a cross-sectional view of the expandable interbody device ofFIG. 1 in a collapsed configuration.
• FIG. 4 is a cross-sectional view of the expandable interbody device ofFIG. 2 in an expanded configuration.
• FIG. 5 is a perspective exploded view showing the expandable interbody device ofFIG. 1, including the outer structure, inner structure and screw mechanism.
• FIG. 6 is a perspective exploded view showing the expandable interbody device ofFIG. 1 with the screw mechanism assembled with the inner structure prior to assembly into the outer structure.
• FIG. 7 is a perspective view showing an expandable interbody device in a collapsed configuration, according to another embodiment of the present invention.
• FIG. 8 is a perspective view showing the expandable interbody device ofFIG. 7 in an expanded configuration.
• FIG. 9 is a cross-sectional view of the expandable interbody device ofFIG. 7 in a collapsed configuration.
• FIG. 10 is a cross-sectional view of the expandable interbody device ofFIG. 8 in an expanded configuration.
• FIG. 11 is a perspective exploded view showing the expandable interbody device ofFIG. 7, including the outer structure, inner structure and screw mechanism.
• FIG. 12 is a perspective view showing an expandable interbody device in a collapsed configuration, according to another embodiment of the present invention.
• FIG. 13 is a top view of the expandable interbody device ofFIG. 12.
• FIG. 14 is a bottom view of the expandable interbody device ofFIG. 12.
• FIG. 15 is a side view of the expandable interbody device ofFIG. 12.
• FIG. 16 is a front view of the expandable interbody device ofFIG. 12.
• FIG. 17 is a rear view of the expandable interbody device ofFIG. 12.
• FIG. 18 is a perspective view showing the expandable interbody device ofFIG. 12 in an expanded configuration.
• FIG. 19 is a perspective exploded view showing the expandable interbody device ofFIG. 12, including the upper structure, lower structure and screw mechanism.
• FIG. 20 is a cross-sectional view of the expandable interbody device ofFIG. 12 in a collapsed configuration.
• FIG. 21 is a cross-sectional view of the expandable interbody device ofFIG. 18 in an expanded configuration.
• FIG. 22 is a perspective view of the expandable interbody device ofFIG. 18 coupled to a deployment tool and being implanted between adjacent vertebrae.
• FIG. 23 is a top view of the expandable interbody device and deployment tool ofFIG. 22.
• FIG. 24 is a top view of the shaft, handle and arms of the deployment tool ofFIG. 22.
• FIG. 25A is a close-up top view of the arms of the deployment tool ofFIG. 22 in an open configuration.
• FIG. 25B is a close-up top view of the arms of the deployment tool ofFIG. 22 in a closed configuration.
• FIG. 26 is a close-up perspective view of the expandable interbody device and deployment tool ofFIG. 22.
• FIG. 27 is a perspective view of an actuation device of the deployment tool ofFIG. 22.
• FIG. 28 is a cross-sectional top view of the deployment tool ofFIG. 22.
• FIG. 29 is a close-up cross-sectional view of the expandable interbody device and deployment tool showing fluid delivery through the screw mechanism.
• FIG. 30 is a side view of the proximal section of the screw mechanism ofFIG. 19.
• FIG. 31 is a rear view of the proximal section of the screw mechanism ofFIG. 19.
• FIG. 32 is a cross-sectional view of the expandable interbody device and deployment tool showing fluid delivery through channels in the delivery tool, according to another embodiment of the present invention.
DETAILED DESCRIPTION
• An expandable interbody device can be configured to have an initial collapsed configuration having a first height suitable for being inserted into an intervertebral space between a pair of adjacent vertebrae, and an expanded configuration having a second height that is greater than the first height. The implant can be expanded from the initial collapsed configuration to the expanded configuration in-situ. The use of a small interbody implant which may be expanded in-situ allows the possibility of performing the surgery percutaneously with minimal disruption to tissues surrounding the surgical site and intervening soft tissue structures, through a minimally invasive or open procedure. The expandable interbody device of the present disclosure can include features that reduce displacement of soft tissue and structures during placement of the expandable interbody device while providing support after placement to the adjacent vertebrae while bone fusion occurs. The expandable interbody device includes a collapsed configuration with dimensions that can allow insertion of the expandable interbody device between the vertebrae. Once the expandable interbody device is positioned in a desired location between the vertebrae, the expandable interbody device may be expanded to an expanded configuration. The expanded configuration can increase the distance between the adjacent vertebrae and provide support to the adjacent vertebrae while bone fusion occurs. The expanded configuration can also provide rigid support between the adjacent vertebrae that withstands compressive forces. The expandable interbody device of the present disclosure may sometimes be referred to as an expandable interbody implant, expandable interbody spacer or expandable corpectomy device, all of which are envisioned for the present disclosure.
• Several non-limiting embodiments will now be described with reference to the figures, wherein like numerals reflect like elements throughout. The terminology used in the description presented herein is not intended to be interpreted in any limited or restrictive way, simply because it is being utilized in conjunction with a detailed description of certain specific embodiments. Furthermore, some embodiments may include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to the devices and methods described herein.
• The words proximal and distal are applied herein to denote specific ends of components of the instrument described herein. A proximal end refers to the end of a component nearer to an operator of the instrument when the instrument is being used. A distal end refers to the end of a component further from the operator and extending towards the surgical area of a patient and/or the implant. The words top, bottom, left, right, upper and lower are used herein to refer to sides of the device from the described point of view. These reference descriptions are not intended to limit the orientation of the implanted interbody device and the device can be positioned in any functional orientation. For example, in some configurations, the interbody device can be used in an upside-down orientation from the specific orientation described herein.
• Referring now toFIGS. 1-6, anexpandable interbody device100 can be a spinal implant that includes anouter structure102, aninner structure104, and ascrew mechanism106. Theexpandable interbody device100 can be movable between a collapsed configuration (shown inFIG. 1) to an expanded configuration (shown inFIG. 2) utilizing thescrew mechanism106.
• Theouter structure102 can include atop surface108, abottom surface110, afront side112, aback side114, and left andright sides116. A combination of thesides112,114 and116 forms a wall that encloses acentral opening118. Thefront side112, backside114, left andright sides116 may have a varying height, length, thickness, and/or curvature radius. The left andright sides116 may include longitudinal openings, slots ortrenches120 configured to interface with an insertion and/or deployment tool (not shown) during implantation and deployment of the device from the collapsed configuration to the expanded configuration. In some embodiments, thefront side112 and theback side114 includeslots122 having inwardly facingramp portions124 on the outer surfaces proximate theslots122. Theslots122 andramp portions124 can interface with thescrew mechanism106. As shown inFIGS. 3 and 4, theramp portions124 slant inward from the bottom toward the top.
• In other embodiments not shown, thefront side112 and theback side114 may include non-ramp features that interface with thescrew mechanism106 to translateinner structure104 relative to theouter structure102 from the collapsed configuration to the expanded configuration. For example, as long as thescrew mechanism106 head geometry and theslots122 or non-ramp features have non-complimentary surfaces, the inner and outer structures may translate and expand. For example, the contact surface of the screw head may be conical or spherical and the outer structure may have a bore with a sharp ledge. As the screw head is drawn toward that ledge, the inner and outer structures may translate and expand.
• Theinner structure104 can include atop surface126, abottom surface128, afront side130, aback side132, and left andright sides134. A combination of thesides130,132 and134 forms an outer wall and inner wall that can enclose acentral opening136. Thecentral opening136 can be configured to receive bone graft material such as allograft and/or Demineralized Bone Matrix (“DBM”) packing. In some embodiments, theinner structure104 may not have acentral opening136 and thetop surface126 can be closed. Theinner structure104 outer wall can be configured to slideably fit within thecentral opening118 of theouter structure102. Thefront side130 can include a distal threadedhole140 and theback side132 can include a proximal threadedhole138 that interface with thescrew mechanism106 and are longitudinally aligned with theslots122 of theouter structure102. The threadedholes138,140 can have threads in opposite directions, one having a left hand thread and the other a right hand thread. With matching opposite threads on thescrew mechanism106, thescrew mechanism106 can contract or extend when turned to expand or collapse the interbody device, as discussed in more detail below. Thefront side130, backside132, left andright sides134 may have a varying height, length, thickness, and/or curvature radius. In some embodiments, when theinner structure104 is positioned within theouter structure102, the height and/or curvature radius of thetop surfaces108,126, and bottom surfaces,110,128, of each should be approximately the same, as shown inFIGS. 1 and 3. In other embodiments, the height and/or curvature radius of each may be different.
• The top surfaces108,126 and the bottom surfaces110,128 of the outer andinner structures102,104 can include a plurality of protrusions or teeth142 (hereinafter, referred to as “teeth”).Teeth142 can be configured to be spaced throughout thetop surfaces108,126 and the bottom surfaces110,128. As can be understood by one skilled in the art, theteeth142 can be configured to have variable thickness, height, and width as well as angles of orientation with respect tosurfaces108,126 and110,128. Theteeth142 can be further configured to provide additional support after theexpandable interbody device100 is implanted in the intervertebral space of the patient. Theteeth142 can reduce movement of theouter structure102 andinner structure104 with the vertebrae and create additional friction between the vertebrae and theouter structure102 andinner structure104.
• In some embodiments, theteeth142 on thetop surfaces108,126 and the bottom surfaces110,128 can be configured to match when theouter structure102 andinner structure104 are joined in the collapsed configuration, as shown inFIG. 1. In other embodiments, theteeth142 on thetop surface108 and thebottom surface110 of theouter structure102 may have different spacing, configuration, thickness, height, and width as well as angles of orientation with respect to theteeth142 on thetop surface126 and thebottom surface128 of theinner structure104. In other embodiments, theouter structure102 and theinner structure104 may only have theteeth142 on surfaces that contact the lower and upper vertebrae in the expanded configuration. For example, theouter structure102 may only haveteeth142 on the bottom surface in contact with the lower vertebrae while theinner structure104 may only have theteeth142 on thetop surface126 in contact with the upper vertebrae.
• In some embodiments, thetop surfaces108,126 and the bottom surfaces110,128 may be a porous or roughened surface, for example, they may be formed of a porous material, coated with a porous material, or chemically etched to form a porous or roughened surface with pores that participate in the growth of bone with the adjacent vertebra.
• As shown in the figures, thescrew mechanism106 can include aproximal section150 and adistal section152 loosely coupled in a keyed configuration, such that when theproximal section150 is rotated, thedistal section152 also rotates as a unit. For example, thedistal section152 may have a keyed shaft outer surface that slideably engages a bore on theproximal section150 having a matching keyed inner surface. Therefore, thedistal section152 does not have to be rigidly connected to theproximal section150. One skilled in the art may appreciate that any suitable shapes or geometric configurations for a keyed connection between the proximal anddistal sections150,152 may be included in thescrew mechanism106 to achieve the desired results.
• In use, thescrew mechanism106 engages theouter structure102 andinner structure104 such that when it is rotated, theinner structure104 translates relative to theouter structure102 from the collapsed configuration to the expanded configuration. If desired, thescrew mechanism106 may be rotated in the opposite direction to translate theinner structure104 from the expanded configuration back to the collapsed configuration. This allows theexpandable interbody device100 to be moved to another location or repositioned if it is expanded in the wrong location and needs to be collapsed prior to moving or repositioning.
• Theproximal section150 and thedistal section152 may be fabricated from any biocompatible material suitable for implantation in the human spine, such as metal including, but not limited to, titanium and its alloys, stainless steel, surgical grade plastics, plastic composites, ceramics, bone, or other suitable materials. In some embodiments, theproximal section150 and thedistal section152 may be formed of a porous material that participates in the growth of bone with the adjacent vertebral bodies. In some embodiments, theproximal section150 and thedistal section152 may include a roughened surface that is coated with a porous material, such as a titanium coating, or the material may be chemically etched to form pores that participate in the growth of bone with the adjacent vertebra. In some embodiments, only portions of theproximal section150 and thedistal section152 may be formed of a porous material, coated with a porous material, or chemically etched to form a porous surface, such as the upper and lower surfaces that contact the adjacent vertebra are roughened or porous. In some embodiments, the surface porosity may be between 50 and 300 microns.
• Theproximal section150 can include ashaft154 with aninternal bore156 extending along its longitudinal axis. In some embodiments,shaft154 has a cylindrical outer surface and the internal bore has a non-cylindrical surface or keyed surface, such as a square or hexagonal inner surface. Theproximal section150 can also include an external screw threadedportion158 configured to couple with the proximal threadedhole138 of theinner structure104. The proximal end of the shaft can include a proximalcircular head160 adapted to receive a driving tool for rotating or driving theproximal section150, and the distal end of theshaft154 can be configured to receive the keyed shaft portion of thedistal section152 within theinternal bore156. Between the externalscrew thread portion158 and thehead160 can be acylindrical engagement portion162 configured to fit within theslot122 of theouter structure102. The distal portion of thehead160 can have aspherical surface164 configured to engage and slide along the proximal curved orramp portion124 of theouter structure102.
• Thedistal section152 can include a distalcircular head166, external screw threadedportion168 configured to couple with the distal threadedhole140 of theinner structure104, acylindrical engagement portion162 positioned between thedistal head166 and externalscrew thread portion168 configured to fit within thedistal slot122 of theouter structure102, and akeyed shaft170 portion. Thekeyed shaft170 portion can be configured to slideably fit within theinternal bore156 of theproximal section150. When joined, thekeyed shaft170 portion andinternal bore156 act as a keyed shaft and sleeve arrangement, such that when theproximal section150 is rotated, thedistal section152 also rotates as a unit. The proximal portion of thehead166 can have aspherical surface172 configured to engage and slide along the distal curved orramp portion124 of theouter structure102, as illustrated inFIGS. 3 and 4.
• As mentioned above, the external screw threadedportions158,168 of thescrew mechanism106 can match the threadedholes138,140 of theinner structure104. Since threadedholes138,140 have thread patterns in opposite directions, the externalscrew thread portions158,168 may also have matching thread patterns in opposite directions. In some embodiments, the threaded holes and external screw thread portions may have equal pitch, such that during expansion, the proximal and distal end of theouter structure102 andinner structure104 translate or move at the same rate. In other embodiments, the proximal threaded hole and proximal external screw thread portion may have a different pitch than the distal threaded hole and distal external screw thread portion, such that during expansion, the proximal and distal ends of theouter structure102 andinner structure104 translate or move at different rates. For example, the proximal end of theouter structure102 andinner structure104 may translate or move at a first rate of speed and the distal end of theouter structure102 andinner structure104 may translate or move at a second rate of speed. The first rate of speed may be faster or slower than the second rate of speed. This allows for some angularity between theouter structure102 andinner structure104 during expansion. The difference between the first and second rates of speed allows the user to select anexpandable interbody device100 that has some angulation after expansion to account for the lordotic curvature of the spine.
• When thescrew mechanism106 is coupled to theinner structure104 it may vary in length during interbody expansion (as shown inFIGS. 3 and 4). Initially, the length of thescrew mechanism106 can be L1 in the collapsed configuration, shown inFIG. 3. As thescrew mechanism106 is rotated in a first direction, it acts like a compression screw and the length of thescrew mechanism106 contracts to L2 in the expanded configuration, shown inFIG. 4, due to the threads on the proximal and distal sections being threaded in opposite directions. By reversing rotation of thescrew mechanism106 in a second direction, opposite the first, thescrew mechanism106 may extend in length from L2 back to L1, if desired.
• Referring toFIGS. 5 and 6, theexpandable interbody device100 can be assembled by inserting theproximal section150 of thescrew mechanism106 into proximal threadedhole138 and thedistal section152 of thescrew mechanism106 into distal threadedhole140. The external screw threadedportions158,168 engage the threadedholes138,140 and thekeyed shaft170 of thedistal section152 is slid within and engaged, or keyed, with theinternal bore156 of theproximal section150. Thescrew mechanism106 is then rotated in the direction for contraction until theengagement portion162 for each section is left exposed (seeFIG. 6). Theinner structure104 may then be lowered into thecentral opening118 of theouter structure102, with theengagement portions162 sliding into the proximal anddistal slots122 of theouter structure102. Thescrew mechanism106 is then rotated until thespherical surface164 of theproximal head158 and thespherical surface172 of thedistal head168 engage the proximal and distal curved orramp portions124 of theouter structure102, shown inFIG. 3. Theexpandable interbody device100 is now ready to be inserted.
• Referring back toFIGS. 3 and 4, in the collapsed configuration theexpandable interbody device100 may have a height of H1. Theproximal head160spherical surface164 is engaged with theproximal ramp portion124 of theouter structure102 and thedistal head166spherical surface172 is engaged with thedistal ramp portion124 of theouter structure102. When thescrew mechanism106 is rotated in a first direction, theproximal head160 and thedistal head166 can move toward each other (from L1 to L2). While this happens, thespherical surfaces164 and172 start sliding up the proximal and distal incline ramps124 and translating theinner structure104 vertically from H1 (collapsed configuration) toward H2 (expanded configuration). Theexpandable interbody device100 does not have to be completely extended to H2 and can be stopped anywhere between H1 and H2, depending on the expansion needed between the adjacent vertebrae. The proximal anddistal ramps124 may also have features that that require more force or less force on thescrew mechanism106 during expansion. This difference in forces may provide tactile feedback to the surgeon as an indication of expansion of theexpandable interbody device100.
• In some embodiments, the screw mechanism may be a compression screw having a proximal section threadably coupled to a distal section, the proximal section having a threaded shaft and the distal section having a threaded bore, such that when the proximal section is rotated, the threaded shaft engages the threaded bore to shorten or lengthen the distance between theproximal head158 and thedistal head168. In this embodiment, holes138,140 would be sized to slideably fit the proximal and distal shafts of the compression screw and would not be threaded holes.
• Theexpandable interbody device100 may also include a deployment tool. The deployment tool may include various attachment features to enable insertion of theexpandable interbody device100 into the patient. For example, the deployment tool may include arms or clamps to attach to the longitudinal openings, slots ortrenches120 of theouter structure102 and an actuation device to couple with thehead160 of theproximal section150 of thescrew mechanism106. Once theexpandable interbody device100 has been inserted and positioned within the intervertebral space between two vertebrae, the deployment tool may actuate to deploy and expand theexpandable interbody device100 by applying a rotational force to screwmechanism106.
• In operation, theexpandable interbody device100 may be inserted into the intervertebral disc space between two vertebrae using an insertion or deployment tool. In some cases, the disc space may include a degenerated disc or other disorder that may require a partial or complete discectomy prior to insertion of theexpandable interbody device100. The deployment tool may engage with the proximal end of theexpandable interbody device100. As the deployment tool applies the rotational force, theexpandable interbody device100 gradually expands as described above. The deployment tool may allow an increase in the amount of force that can be applied to thescrew mechanism106 to overcome the friction or interference between thespherical surfaces164,172 of the distal and proximal heads and ramp portions of theouter structure104 during expansion of theexpandable interbody device100. The increase in the force may be used to provide tactile feedback to the surgeon indicating near complete deployment of theexpandable interbody device100.
• In some embodiments, more than oneexpandable interbody device100 can be implanted between the adjacent vertebrae of the patient. In such embodiments, multiple expandableinterbody devices100 can be placed in a side-by-side configuration or any other suitable configuration, thereby creating additional support.
• Referring now toFIGS. 7-11, anexpandable interbody device200 can be a spinal implant that includes anouter structure202, aninner structure204, and ascrew mechanism206. Theexpandable interbody device200 can be movable between a collapsed configuration (show inFIG. 7) to an expanded configuration (shown inFIG. 8) utilizing thescrew mechanism206.
• Referring now toFIG. 11, theouter structure202 can include atop surface208, abottom surface210, afront side212, aback side214, and left andright sides216. A combination of thesides212,214 and216 can form a wall that encloses acentral opening218. Thefront side212, backside214, left andright sides216 may have a varying height, length, thickness, and/or curvature radius. The left andright sides216 may include longitudinal openings, slots ortrenches220 configured to interface with an insertion and/or deployment tool (not shown) during implantation and deployment of the device from the collapsed configuration to the expanded configuration. Thefront side212 and theback side214 can haveholes222 sized to slideably fit portions of thescrew mechanism206, seeFIGS. 9 and 10.
• Theinner structure204 can include aninner portion204aand a lowerflanged portion204b. Theinner portion204acan include atop surface226, afront side230a, aback side232a, and left andright sides234a. In the illustrated embodiment, a combination of thesides230a,232aand234aforms an outer wall and inner wall that encloses acentral opening236. Theinner portion204aouter wall can be configured to slideably fit within thecentral opening218 of theouter structure202, as shown in the figures. Thefront side230aand theback side232acan includeslots223 sized to slideably fit thescrew mechanism206 threads. Theholes222 of theouter structure202 are aligned with theslots223.
• The lowerflanged portion204bof theinner structure204 can include abottom surface228, afront side230b, aback side232b, and left andright sides234b. A combination of thesides230b,232band234bforms an outer wall and inner wall. The inner wall of the lowerflanged portion204bcan also enclose thecentral opening236.
• On the inner wall of thefront side230aandback side232aare inwardly facingramps224 proximate theslots223 within thecentral opening236 of theinner structure204 that interface with thescrew mechanism206, shown inFIGS. 9 and 10.
• Thefront sides230a,230b, back sides232a,232b, left andright sides234a,234b, may have a varying height, length, thickness, and/or curvature radius. In some embodiments, when theinner structure204 is positioned within theouter structure202, the curvature radius of thetop surfaces208,226 can be approximately the same, as shown inFIGS. 7 and 9. In other embodiments, the curvature radius of each may be different. In some embodiments, the outer wall of the lowerflanged portion204bis approximately the same shape as the outer wall of theouter structure202, as shown inFIGS. 7 and 9. In other embodiments, the outer wall of each may be different. Thecentral opening236 can be configured to receive bone graft material such as allograft and/or Demineralized Bone Matrix (“DBM”) packing.
• The top surfaces208,226 and thebottom surface228 of the outer andinner structures202,204 can include a plurality of protrusions or teeth242 (hereinafter, referred to as “teeth”).Teeth242 can be configured to be spaced throughout thetop surfaces208,226 and thebottom surface228. As can be understood by one skilled in the art, theteeth242 can be configured to have variable thickness, height, and width as well as angles of orientation with respect tosurfaces208,226 and228. Theteeth242 can be further configured to provide additional support after theexpandable interbody device200 is implanted in the intervertebral space of the patient. Theteeth242 can reduce movement of theouter structure202 andinner structure204 with the vertebrae and create additional friction between the vertebrae and theouter structure202 andinner structure204.
• In some embodiments, theteeth242 on thetop surfaces208,226 can be configured to match when theouter structure202 andinner structure204 are joined in the collapsed configuration, as shown inFIG. 7. In other embodiments, theteeth242 on thetop surface208 of theouter structure202 may have different spacing, configuration, thickness, height, and width as well as angles of orientation with respect to theteeth242 on thetop surface226 of theinner structure204. In other embodiments, theouter structure202 and theinner structure204 may only have theteeth242 on surfaces that contact the lower and upper vertebrae in the expanded configuration. For example, theouter structure202 may only haveteeth242 on thetop surface208 in contact with the first vertebrae while theinner structure204 may only have theteeth242 on thebottom surface228 in contact with the second vertebrae.
• In some embodiments, thetop surfaces208,226 and thebottom surface228 may be a porous or roughened surface, for example, they may be formed of a porous material, coated with a porous material, or chemically etched to form a porous or roughened surface with pores that participate in the growth of bone with the adjacent vertebra.
• Theproximal section250 and thedistal section252 of thescrew mechanism206 may be fabricated from any biocompatible material suitable for implantation in the human spine, such as metal including, but not limited to, titanium and its alloys, stainless steel, surgical grade plastics, plastic composites, ceramics, bone, or other suitable materials. In some embodiments, theproximal section250 and thedistal section252 may be formed of a porous material that participates in the growth of bone with the adjacent vertebral bodies. In some embodiments, theproximal section250 and thedistal section252 may include a roughened surface that is coated with a porous material, such as a titanium coating, or the material is chemically etched to form pores that participate in the growth of bone with the adjacent vertebra. In some embodiments, only portions of theproximal section250 and thedistal section252 may be formed of a porous material, coated with a porous material, or chemically etched to form a porous surface, such as the upper and lower surfaces that contact the adjacent vertebra are roughened or porous. In some embodiments, the surface porosity may be between 50 and 300 microns.
• As shown in the figures, thescrew mechanism206 can include ashaft254, a proximal rampedcomponent264 and a distal rampedcomponent272. The proximal end of the shaft can include anopening260 adapted to receive a driving tool for rotating theshaft254. The proximal and distal rampedcomponents264,272 can have threadedholes238,240 with threads in opposite directions,hole238 having a left hand thread and hole240 a right hand thread, or vice versa. In the illustrated embodiment, theshaft254 includesproximal section250 withexternal threads258, anddistal section252 withexternal threads268 in opposite directions,external threads258 having a left hand thread andexternal thread268 having a right hand thread, or vice versa, matching thethreads238,240 of the proximal and distal rampedcomponents264,272. When assembled, proximal rampedcomponent264 is threaded onto theproximal thread258 of theproximal section250 while the distal rampedcomponent272 is threaded onto thedistal thread268 of thedistal section252. Having opposite threads on the proximal and distal rampedcomponents264,272 matching the proximal anddistal sections250,252 can allow the proximal and distal rampedcomponents264,272 to extend or contract along theshaft254 when thescrew mechanism206 is rotated or turned to expand or collapse the interbody device (see below).
• In use, the proximal and distal rampedcomponents264,272 of thescrew mechanism206 can engage the inwardly facingramps224 and the proximal anddistal sections250,252 can extend throughslots223 of theinner structure204 and intoholes222 of the outer structure202 (shown inFIGS. 9 and 10). When thescrew mechanism206 is rotated, the proximal and distal rampedcomponents264,272 move along theshaft254 and slide along the inwardly facingramps224 of theinner structure204 and the proximal anddistal sections250,252 slide inslots223 of theinner structure204, while the extreme part of the proximal anddistal sections250,252 stay within theholes222 of theouter structure202. This action translates theinner structure204 relative to theouter structure202 from the collapsed configuration to the expanded configuration. If desired, thescrew mechanism206 may be rotated in the opposite direction to translate theinner structure204 from the expanded configuration back to the collapsed configuration. This can allow theexpandable interbody device200 to be moved to another location or reposition if it is expanded in the wrong location and needs to be collapsed prior to moving or repositioning. Theshaft254, the proximal and distal rampedcomponents264,272, theouter structure202 andinner structure204 may be fabricated from any biocompatible material such as stainless steel, or other suitable material.
• As discussed above, the external screw threadedportions258,268 can match the threadedholes238,240 of the rampedcomponents264,272. Since threadedholes238,240 may have thread patterns in opposite directions, the externalscrew thread portions258,268 may also have matching thread patterns in opposite directions. In some embodiments, the threaded holes and external screw thread portions may have equal pitch, such that during expansion, the proximal and distal end of theouter structure202 andinner structure204 translate or move at the same rate. In other embodiments, the proximal threaded hole and proximal external screw thread portion may have a different pitch than the distal threaded hole and distal external screw thread portion, such that during expansion, the proximal and distal ends of theouter structure202 andinner structure204 translate or move at different rates. For example, the proximal end of theouter structure202 andinner structure204 may translate or move at a first rate of speed and the distal end of theouter structure202 andinner structure204 may translate or move at a second rate of speed. The first rate of speed may be faster or slower than the second rate of speed. This can allow for some angularity between theouter structure202 andinner structure204 during expansion. The difference between the first and second rates of speed can allow the user to select anexpandable interbody device200 that has some angulation after expansion to account for the lordotic curvature of the spine.
• When thescrew mechanism206 is coupled to theinner structure204 the distance between the rampedcomponents264,272 can vary in length during interbody expansion (as shown inFIGS. 9 and 10). Initially, the distance is L3 in the collapsed configuration, shown inFIG. 9. As thescrew mechanism206 is rotated in a first direction, the distance between the rampedcomponents264,272 can extend in length to L4 in the expanded configuration, shown inFIG. 10, due to the threads on the proximal and distal sections and ramped components being threaded in opposite directions. By reversing rotation of thescrew mechanism206 in a second direction, opposite the first, the distance may shorten in length from L4 back to L3, if desired.
• Referring back toFIGS. 9 and 10, in the collapsed configuration theexpandable interbody device200 can have a height of H3. The proximal rampedcomponent264 can be engaged with theproximal ramp portion224 and the distal rampedcomponent272 can be engaged with thedistal ramp portion224 of theinner structure204. When thescrew mechanism206 is rotated in a first direction, the proximal rampedcomponent264 and the distal rampedcomponent272 can move away from each other (from L3 to L4). While this happens, the proximal and distal rampedcomponents264 and272 are forced against the proximal and distal incline ramps224, sliding the proximal and distal incline ramps224 in a downward direction, translating theinner structure204 vertically downward from H3 (collapsed configuration) toward H4 (expanded configuration). Theexpandable interbody device200 does not have to be completely extended to H4 and can be stopped anywhere between H3 and H4, depending on the expansion needed between the adjacent vertebrae. The proximal anddistal ramps224 may also have features that that require more force or less force on thescrew mechanism206 during expansion. This difference in forces may provide tactile feedback to the surgeon as an indication of expansion of theexpandable interbody device200.
• Theexpandable interbody device200 may also include a deployment tool. The deployment tool may include various attachment features to enable insertion of theexpandable interbody device200 into the patient. For example, the deployment tool may include arms or clamps to attach to the longitudinal openings, slots ortrenches220 of theouter structure202 and an actuation device to couple with thehead260 of theproximal section250 of thescrew mechanism206. Once theexpandable interbody device200 has been inserted and positioned within the intervertebral space between two vertebrae, the deployment tool may actuate to deploy and expand theexpandable interbody device200 by applying a rotational force to screwmechanism206.
• In operation, theexpandable interbody device200 may be inserted into the intervertebral disc space between two vertebrae using an insertion or deployment tool. In some cases, the disc space may include a degenerated disc or other disorder that may require a partial or complete discectomy prior to insertion of theexpandable interbody device200. The deployment tool may engage with the proximal end of theexpandable interbody device200. As the deployment tool applies the rotational force, theexpandable interbody device200 can gradually expand as described above. The deployment tool may allow an increase in the amount of force that can be applied to thescrew mechanism206 to overcome the friction or interference between the proximal and distal rampedcomponents264,272 andramp portions224 of theinner structure204. The increase in the force may be used to provide tactile feedback to the surgeon indicating near complete deployment of theexpandable interbody device200.
• In some embodiments, more than oneexpandable interbody device200 can be implanted between the adjacent vertebrae of the patient. In such embodiments, multiple expandableinterbody devices200 can be placed in a side-by-side configuration or any other suitable configuration, thereby creating additional support.
• With reference toFIGS. 12-19, some embodiments of theexpandable interbody device300 can include anupper structure302, alower structure304, and ascrew mechanism306. Theexpandable interbody device300 can be changeable between a collapsed configuration, as shown inFIG. 12, to an expanded configuration, as shown inFIG. 18.
• Theupper structure302 can include atop surface308, adistal side312, aproximal side314, and left andright sides316. One ormore slots318 can extend through theupper structure302, having an opening on thetop surface308 that is in fluid communication with the bottom of theupper structure302. The one ormore slots318 can be configured to receive fluids, medication, bone graft material, or other material to help in the integration of the interbody device with the vertebrae, such as with allograft and/or Demineralized Bone Matrix (“DBM”) packing. Thedistal side312,proximal side314, and left andright sides316 may have a varying height, length, thickness, and/or curvature radius. In some embodiments, theupper structure302 may not have any slots and thetop surface308 can be closed. In some embodiments, theupper structure302 can have one ormore markers319 to help visualization using radiation during the implantation procedure. Themarker319 can be made of a radiopaque material, such as titanium.
• Thelower structure304 can include abottom surface328, adistal side330, aproximal side332, and left andright sides334. One ormore slots336 can extend through thelower structure304, having an opening on thebottom surface328 that is in fluid communication with the top of thelower structure304. In some embodiments, the one ormore slots336 may line up with the one ormore slots318 on theupper structure302, such that the slots extend through theinterbody device300. The one ormore slots336 can be configured to receive fluids, medication or other material to help in the integration of the interbody device with the vertebrae, such as with allograft and/or Demineralized Bone Matrix (“DBM”) packing. Thedistal side330,proximal side332, and left andright sides334 may have a varying height, length, thickness, and/or curvature radius. In some embodiments, thelower structure304 may not have any slots and thebottom surface328 can be closed. In some embodiments, thelower structure304 can have one ormore markers337 to help visualization using radiation during the implantation procedure. Themarker337 can be made of a radiopaque material, such as titanium. The left andright sides334 may includerecesses320 configured to interface with a deployment tool during implantation and deployment of the device from the collapsed configuration to the expanded configuration, as explained below. In some embodiments, therecesses320 can extend through to the inner cavity of the interbody device and can be used as an access location for delivering fluids, medication or other material, as discussed below.
• Thetop surface308 of theupper structure302 and thebottom surface328 of thelower structure304 can have a roughened surface, such as a plurality of protrusions orteeth342. The protrusions can be configured to be spaced throughout thetop surface308 and thebottom surface328. As can be understood by one skilled in the art, the protrusions can be configured to have variable thickness, height, and width as well as angled surfaces. For example, as illustrated inFIG. 15, thetop surface308 andbottom surface328 can haveteeth342 that are angled toward the proximal side. The distal facing side of theteeth342 are less steep than the proximal facing side of theteeth342. This can allow for easy insertion of the interbody device and help prevent backing out of the device from the intervertebral space. Theteeth342 can be configured to provide additional support after theexpandable interbody device300 is implanted in the intervertebral space of the patient. For example, the friction between the vertebrae and theupper structure302 andlower structure304, provided at least in part by theteeth342, can help reduce movement of theinterbody device300 in the intervertebral space.
• Theupper structure302 andlower structure304, or portions thereof, can be made of any of a variety of materials known in the art, including but not limited to a polymer such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene, fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia, alumina, or silicon nitride; a metal such as titanium, titanium alloy, cobalt chromium or stainless steel; or any combination of the above materials. Theinterbody device300 may be made of multiple materials in combination. For example, theupper structure302 can comprise a polymer, such as PEEK or polyethylene, and thelower structure304 can comprise a metal or ceramic.
• In some embodiments, theupper structure302 and/or thelower structure304 may be formed of a porous material or have a roughened surface. The surfaces may be formed of a porous material, coated with a porous material, or chemically etched to form a porous or roughened surface with pores, which may help participate in the growth of bone with the adjacent vertebra. In some embodiments, only portions of theinterbody device300 may be formed of a porous material, coated with a porous material, or chemically etched to form a porous surface. For example, at least some portions of thetop surface308 and/or thebottom surface328 can be coated with a porous material, such as a titanium coating. In some embodiments, the surface porosity may be at least approximately 50 microns and less than or equal to approximately 300 microns.
• Theupper structure302 can be configured to slideably fit with thelower structure304. For example, in the embodiment illustrated inFIG. 21 theupper structure302 has smooth surfaces on its sides that slide against smooth surfaces on the sides of thelower structure304 to form a slide bearing. In other embodiments, the upper structure and lower structure can have any of a plurality of different types of functional couplers to form a slideable connection.
• Thedistal sides312,330 and theproximal sides314,332 of thetop surface308 andbottom surface328 can have ascrew opening322 that accepts thescrew mechanism306, as illustrated inFIG. 21. The outer surfaces of thescrew opening322 can have anangled surface324. Theangled surface324 can flare outward toward the surface, such that thescrew opening322 is larger at the surface of the distal side or proximal side than the opening in toward the middle. When theupper structure302 and thelower structure304 are in the collapsed configuration, theangled surfaces324 can form a frustoconical shape. Theupper structure302 can have approximately half of the cone and the lower structure can have approximately half of the cone. Theangled surfaces324 can interface with thescrew mechanism306 to transition theinterbody device300 from the collapsed to expanded configuration, as explained below.
• With reference toFIG. 19, thescrew mechanism306 can include aproximal section350, adistal section352 and acoupler380. Thecoupler380 can have aproximal hole382 configured to engage theproximal section350 and adistal hole384 configured to engage thedistal section352. Theholes382,384 can have threads in opposite directions (i.e., one having a left hand thread and the other a right hand thread). Theproximal section350 can have threads that are configured to engage threads in theproximal hole382 and thedistal section352 can have threads that are configured to engage threads in thedistal hole384. In the illustrated embodiment, theproximal section350 anddistal section352 have external threads while thecoupler380 has internal threads. In other embodiments, the coupler can have external threads while the proximal section and distal section have internal threads. As discussed in more detail below, the threads in opposite directions enable thescrew mechanism306 to contract or extend when rotated.
• Thecoupler380 can includeprotrusions386 configured to engage withapertures388,390 in theupper structure302 andlower structure304, respectively, to prevent thecoupler380 from rotating as theproximal section350 of is rotated with a drive tool. In the illustrated embodiment ofFIGS. 12-19, thecoupler380 includes twoprotrusions386 having oval shaped extensions that fit into oval-shapedapertures388,390. In other embodiments, the protrusions can have any of a variety of shapes, such as cylindrical or rectangular extensions.
• Theproximal section350 can include a threadedportion358 configured to engage the threads on theproximal hole382 of thecoupler380. The proximal end of theproximal section350 can include ahead360 with adrive interface361 adapted to receive a driving tool for rotating or driving theproximal section350. In the illustrated embodiment, thehead360 has a hexagonal shaped cavity for receiving a hexagonal drive wrench. In other embodiments, the head can have any of a variety of drive interfaces, such as slotted, cross and polygonal heads. The distal end of theproximal section350 can have abore356 extending along its longitudinal axis configured to receive ashaft370 of thedistal section352. The distal facing side of thehead360 can have anangled surface364 configured to slide and press against theangled surfaces324 of theupper structure302 andlower structure304. For example, theangled surface364 can be a tapered cylindrical surface (i.e., a frustoconical shape as illustrated inFIG. 19), with sufficient smoothness to functionally slide and press against the angled surfaces324.
• Thedistal section352 can include ahead366 and a threadedportion368 configured to couple with thedistal hole384 of thecoupler380. Thedistal section352 can also have ashaft370 extending proximally along the longitudinal axis that is configured to slideably couple with thebore356 of theproximal section350. As described below, theshaft370 and bore356 can be keyed, such that when theproximal section350 is rotated, thedistal section352 also rotates as a unit. The proximal facing side of thehead366 can have anangled surface372 configured to slide against theangled surfaces324 of theupper structure302 andlower structure304, as illustrated inFIGS. 20 and 21.
• Theproximal section350 and thedistal section352 can be rotatably linked with a keyed coupling, such that when theproximal section350 is rotated, thedistal section352 also rotates as a unit. Theshaft370 on thedistal section352 can have a keyed shape that slideably engages with thebore356, on theproximal section350, which has a matching keyed shape. In the embodiment illustrated inFIG. 21, theshaft370 has a square cross-sectional shape that slideably engages abore356 having a square cross-sectional shape. Other suitable shapes or geometric configurations for a keyed connection between theproximal section350 anddistal section352 may be used in thescrew mechanism306 to achieve the desired results, such as triangular, hexagonal, oval, star-shaped, or other non-circular shape.
• In use, thedrive interface361 can be actuated to compress thescrew mechanism306, which engages theupper structure302 andlower structure304 to move the two structures away from each other from the collapsed configuration to the expanded configuration. If desired, thedrive interface361 may be actuated in the opposite direction to change theinterbody device300 from the expanded configuration back to the collapsed configuration. This allows theexpandable interbody device300 to be moved to another location or repositioned if it is expanded in the wrong location and needs to be collapsed prior to moving or repositioning.
• With reference toFIGS. 20 and 21, thescrew mechanism306 can vary in length to change the interbody device from the collapsed configuration to the expanded configuration. Initially, the length of thescrew mechanism306 can be L5 in the collapsed configuration, shown inFIG. 20. As thedrive interface361 is rotated in a first direction, theproximal section350 and thedistal section352 are screwed into thecoupler380 and the length of thescrew mechanism306 contracts to L6 in the expanded configuration, shown inFIG. 21. Theprotrusions386 on thecoupler380 are constrained in theapertures388,390 on theupper structure302 andlower structure304 to prevent thecoupler380 from rotating with theproximal section350 anddistal section352 as thedrive interface361 is rotated. By reversing rotation of thedrive interface361 in a second direction, opposite the first, thescrew mechanism306 can be extended in length from L6 back to L5, if desired.
• In the embodiment illustrated inFIGS. 20 and 21, in the collapsed configuration theexpandable interbody device300 has a distance of H5. Theangled surface364 of theproximal section350 can contact theproximal ramp portions324 of theupper structure302 andlower structure304. Theangled surface372 of thedistal section352 can engage thedistal ramp portions324 of theupper structure302 andlower structure304. When thedrive interface361 is rotated in a first direction, theproximal section350 and thedistal section352 can move toward each other from L5 to L6, as explained above. When this happens, theangled surfaces364 and372 can push against theangled surfaces324 of theupper structure302 andlower structure304, causing theupper structure302 andlower structure304 to separate. The distance between theupper structure302 and thelower structure304 can increase from H5 (collapsed configuration) to H6 (expanded configuration). Theexpandable interbody device300 does not have to be completely expanded to H6 and may only be expanded to a partial distance between H5 and H6, depending on the expansion needed between the adjacent vertebrae. The proximal and distalangled surfaces324 can have features that increase resistance to turning of thescrew mechanism306, so that increased actuating forces are required during select portions of the expansion procedure. This variation of actuating forces can provide tactile feedback to the surgeon as an indication of expansion position of theexpandable interbody device300, such as when theinterbody device300 is nearing the limits of its expansion.
• As mentioned above, the threadedportion358 of theproximal section350 can engage with theproximal hole382 of thecoupler380 and the threadedportion368 of thedistal section352 can engage with thedistal hole384 of thecoupler380. Theproximal hole382 anddistal hole384 can have thread patterns in opposite directions and thethread portions358,368 can have corresponding thread patterns in opposite directions. In some embodiments, the proximal anddistal holes382,384 and thethread portions358,368 may have equal pitch, such that during expansion, the proximal side and distal side of theupper structure302 andlower structure304 translate or move at the same rate. In other embodiments, theproximal hole382 and threadedportion358 of theproximal section350 may have a different pitch than thedistal hole384 and threadedportion368 of thedistal section352, such that during expansion, the proximal side and distal side of theupper structure302 andlower structure304 translate or move at different rates. For example, the proximal side of theupper structure302 andlower structure304 may translate or move at a first rate of speed and the distal side of theupper structure302 andlower structure304 may translate or move at a second rate of speed. The first rate of speed may be faster or slower than the second rate of speed. This allows for some angularity between theupper structure302 andlower structure304 during expansion. The difference between the first and second rates of speed allows the user to select an expandable interbody device that has some angulation after expansion, for example to account for the lordotic curvature of the spine.
• Thescrew mechanism306 or portions of thescrew mechanism306 can be fabricated from any biocompatible material suitable for implantation in the human spine, such as metals including, but not limited to, stainless steel, titanium and titanium alloys, as well as surgical grade plastics, plastic composites, ceramics, bone, and other suitable materials. In some embodiments, theproximal section350 and thedistal section352 may be formed of a porous material that participates in the growth of bone with the adjacent vertebral bodies. In some embodiments, thescrew mechanism306 can include a roughened surface that is coated with a porous material, such as a titanium coating, or the material may be chemically etched to form pores that participate in the growth of bone with the adjacent vertebra. In some embodiments, only portions of thescrew mechanism306 may be formed of a porous material, coated with a porous material, or chemically etched to form a porous surface, such as thehead360 of theproximal section350 andhead366 of thedistal section352, which may be exposed to the native anatomy after implant. In some embodiments, the surface porosity may be between 50 and 300 microns.
• In some embodiments, the screw mechanism may be a compression screw having a proximal section threadably coupled to a distal section, the proximal section having a threaded shaft and the distal section having a threaded bore, or vice-versa, such that when the proximal section is rotated, the threaded shaft engages the threaded bore to shorten or lengthen the distance between the proximal head and the distal head. The distal section can have anti-rotational features, such as for example an oblong head shape, to prevent it from rotating as the proximal section is engaged with distal section.
• With reference toFIG. 22, adeployment tool400 can be used to implant theinterbody device300 into the patient. In use, anincision10 can be made on the patient to allow access to the implant site in theintervertebral space20. The incision can be made for implanting the device from the posterior, lateral or anterior directions. The incision can be small for a minimally invasive procedure or a larger incision can be used for an open surgery. Once the implant site is accessed, the twoadjacent vertebrae30 can be distracted in some situations to open up theintervertebral space20. In some situations, theexpandable interbody device300 can be used to at least partially distract the vertebrae during the implant procedure. In some situations, theintervertebral space20 may include a degenerated disc or other disorder that may require a partial or complete discectomy prior to insertion of theexpandable interbody device300.
• In some configurations, more than oneexpandable interbody device300 can be implanted between the adjacent vertebrae of the patient. In such embodiments, multiple expandableinterbody devices300 can be placed in a side-by-side configuration or any other suitable configuration, thereby creating additional support.
• With reference toFIG. 23, thedeployment tool400 can have anelongate shaft406 with a coupling feature toward thedistal side401 that is configured to secure aninterbody device300. Theproximal side403 of thedeployment tool400 can include ahandle408 attached to theshaft406. Ahollow sleeve410 can be disposed over theshaft406 such that the longitudinal axis of theshaft406 is generally coincident with the longitudinal axis of thesleeve410. Thesleeve410 is movably attached to theshaft406 and is configured to translate along the longitudinal axes. Anactuation device420 can extend through the length of thedeployment tool400 such that a drive of theactuation device420 is at thedistal side401 and a knob is toward theproximal side403.
• The coupling feature includesarms402 or clamps that engage with therecesses320 of thelower structure304 of theinterbody device300. As shown in the close-up views ofFIGS. 25A-B, thearms402 can haveprotrusions404 that are configured to be retained by therecesses320 of theinterbody device300. Thearms402 can be moved from an open configuration to a closed configuration by manipulation of atranslation mechanism412. In the open configuration, illustrated inFIG. 25A, thesleeve410 is in its proximal position, allowing thearms402 to be spread apart sufficiently to fit around theinterbody device300. In the closed configuration, illustrated inFIG. 25B, thesleeve410 is in its distal position and the walls of thesleeve410 can compress thearms402 together around theinterbody device300.FIG. 26 shows a close-up view of thearms402 of thedeployment tool400 coupled to ainterbody device300. Thearms402 can haveprotrusions404 that engage therecesses320 on theinterbody device300. In some configurations, thearms402 can have rails that engage with slots on theinterbody device300.
• In other embodiments, the deployment tool can be coupled to the interbody device through other mechanisms, such as rotational (e.g., threaded) engagement, temporary adhesives, clips, hooks, and the like. Thedeployment tool400 can include any of a variety of suitable attachment features to couple thedeployment tool400 to theinterbody device300.
• With continued reference toFIG. 23, thesleeve410 can have atranslation mechanism412 toward the proximal end that is configured to actuate the coupling feature. In the illustrated embodiment, thetranslation mechanism412 is manipulated by rotation to move thesleeve410 longitudinally relative to theshaft406. In some configurations, thetranslation mechanism412 and the distal part of thesleeve410 can be rotatably coupled such that rotation of thetranslation mechanism412 is translated to linear movement of the distal part of thesleeve410. In other configurations, thetranslation mechanism412 may be rigidly connected to the distal part of thesleeve410 such that theentire sleeve410 rotates as it translates. The inner surface of thetranslation mechanism412 can have threads that engagethreads414 on theshaft406, as illustrated inFIG. 24. The threaded coupling between theshaft406 and thesleeve410 may provide increased mechanical advantage for securing thearms402 around theinterbody device300.
• In some configurations, thesleeve410 can be slideably connected to theshaft406, in which case thesleeve410 is manipulated by pushing and pulling. Other means of coupling the sleeve to the shaft such that an actuation of the translation mechanism results in a desired corresponding movement of the sleeve are possible and are considered within the scope of the disclosure. Thedeployment tool400 can be straight or curved or a combination of these shapes. In some configurations, the deployment tool can have a variable angle shaft such that the shape of the tool can be adjusted during use. For example, the deployment tool can have a hinge that adjusts the bend angle of the shaft for improved fitment of the deployment tool through the incision and to the target implant site. Thedeployment tool400 can be stiff, bendable, or partially stiff and partially bendable. In still other embodiments, a power source may be provided for hydraulic, pneumatic or other power-assisted manipulation of thesleeve410.
• With continued reference toFIG. 23, thedeployment tool400 can include anactuation device420 that extends the length of thedeployment tool400 for actuating thedrive interface361 from the proximal portion of thedeployment tool400. Theactuation device420 can have a distal portion configured to engage thedrive interface361 of theproximal section350 of thescrew mechanism306, and a proximal portion for actuation. For example, the embodiment illustrated inFIG. 27 shows anactuation device420 with anelongate shaft422 that extends the length of thedeployment tool400. Aknob424 can be disposed at the proximal end of theshaft422 to enable the user to rotate theactuation device420. In other configurations, the proximal end can have a lever, flat protrusion, drive interface or other suitable rotational mechanism for manipulating the actuation device. The distal end of theshaft422 can have adrive426 configured to engage thedrive interface361. For example, thedrive426 can be a hexagonal-shaped driver, or any other shape that is complementary to thedrive interface361 cavity of thescrew mechanism306.
• In operation, theactuation device420 can be placed through a passageway extending through the center of thedeployment tool400, as illustrated in the cross-sectional view ofFIG. 28. After theexpandable interbody device300 is inserted and positioned within theintervertebral space20 between twovertebrae30, theactuation device420 can be used to deploy and expand theexpandable interbody device300 by applying a rotational force to theactuation device420. By rotating theknob424 at the proximal portion of thedeployment tool400, thedrive426 is also rotated, which in turn rotates thedrive interface361 of thescrew mechanism306 and expand theinterbody device300.
• As thedeployment tool400 applies the rotational force, theexpandable interbody device300 gradually expands as described above. Theinterbody device300 can be expanded until it contacts the two adjacent vertebrae. In some configurations, theinterbody device300 can be used to distract the two adjacent vertebrae and open up theintervertebral space20. Theactuation device420 can advantageously transmit sufficient torque to thescrew mechanism306 to enable distraction using theinterbody device300. In some configurations, theactuation device420 can have a torque-limiting feature to prevent over-tightening of thescrew mechanism306. For example, the torque-limiting feature can include a spring-loaded clutch mechanism along theshaft422 of theactuation device420 that can only transmit a predetermined amount of torque before the clutch slips. The amount of torque that can be transmitted can depend on the stiffness of the clutch spring. In other embodiments, the torque-limiting feature can be a portion of theshaft422 that is configured to break at a predetermined torque. In other embodiments, the feature can be any functional torque-limiting device.
• In some embodiments, thedeployment tool400 can be used to deliver fluids, medication or other materials, especially materials that can help in the integration of the interbody device with the vertebrae, such as allograft, Demineralized Bone Matrix (“DBM”) packing, and/or other bone graft material. The material can also fill up the empty cavity created between theupper structure302 andlower structure304 upon expansion, helping to provide support to the vertebrae.
• With reference toFIG. 29, adelivery tube430 can extend the length of thedeployment tool400 from theproximal side403 of thedeployment tool400 to the proximal section of thescrew mechanism306. Thedelivery tube430 can have achannel432 extending the length of thedelivery tube430 and open at the distal end so that it is in fluid communication with thedrive interface361 of theproximal section350 of thescrew mechanism306. In some embodiments, thedelivery tube430 is the same as the actuation device except with a channel extending longitudinally through it. Theactuation device420 can be a separate component that is removed from thedeployment tool400 to insert thedelivery tube430. In some embodiments, thedelivery tube430 andactuation device420 are the same component that serves both functions. For example, the actuation device can have a distal end configured to engage thedrive interface361 and a channel extending through its length.
• In some configurations, the material is forced through thedelivery channel432 by a pressurized delivery system. For example, a powered compressor can be attached to the proximal end of thedelivery tube430 to push material through thedelivery channel432 and into the cavity of theinterbody device300. In some configurations, the fluids, medication or other material is delivered to theinterbody device300 by manually pushing the material through the delivery tube, for example by using a push rod. The push rod can be an elongate shaft that closely fits the inside diameter of the delivery channel. The push rod can have a force multiplier to provide increased mechanical advantage for pushing the material through the delivery channel. For example, the push rod can be threadedly engageable with the delivery tube such that the material is pressed through the delivery channel as the push rod is screwed onto the delivery tube. In another example, the push rod can include a ratcheting handle that provides leverage to help push material through the delivery channel.
• With reference toFIGS. 30 and 31, theproximal section350 of the screw mechanism can haveinjection holes359 that extend from thedrive interface361 to theangled surface364. Theproximal section350 can have one, two, three, or more injection holes359. In the illustrated embodiment, the injection holes359 are round holes. In other embodiments, the injection holes can be any of a variety of shapes, such as square, oval or polygonal. The injection holes can provide fluid communication between thedelivery channel432 and the interior of theinterbody device300. In the illustrated embodiment ofFIG. 23, the delivered material travels through thechannel432, into thedrive interface361, through the injection holes359 and into the cavity between theupper structure302 andlower structure304. The material can fill up the cavity and also travel through theslots318 in theupper structure302 and theslots336 in thelower structure304 to come into contact with the vertebrae.
• As illustrated in cross-sectional top view ofFIG. 32, the fluids, medication or other materials can be delivered through thearms402′ of thedeployment tool400′.Channels432′ can extend through thearms402′ and have an opening at the tips of thearms402′. When thedeployment tool400′ is coupled with theinterbody device300, the opening in thearms432′ can be positioned in therecesses320 of thelower structure304, placing thechannels432′ in fluid communication with the interior cavity of theinterbody device300. This configuration advantageously allows the materials to be delivered to theinterbody device300 through existing components without having to introduce a separate pathway.
• The deployment tool can be made of any appropriate material for the particular part. Materials can include, but are not limited to, stainless steel, surgical steel, cutlery steel, tool steel, cobalt and its alloys, nickel and its alloys, chromium and its alloys, titanium and its alloys, zirconium and its alloys, aluminum and its alloys, magnesium and its alloys, polymers, elastomers, and ceramics. Ceramics may include, but are not limited to silicon carbide, silicon oxide(s), silicon nitride, aluminum oxide, alumina, zirconia, tungsten carbide, other carbides.
• The sizes of the interbody device and deployment tool are appropriate for treating the particular bone. Smaller devices can be used for smaller vertebra and larger devices for larger vertebra. In addition, the device can be used on bones other than the vertebra and on bones for humans and non-humans.
• A method of implanting theinterbody device300 comprises coupling theinterbody device300 to thedeployment tool400. Thedeployment tool400 can engage theinterbody device300 by manipulating thetranslation mechanism412 to clamp thearms402 onto therecesses320. Anincision10 can be made on the patient to allow access to the implant site in theintervertebral space20. The incision can be made for implanting the device from the posterior, lateral or anterior directions. The incision can be small for a minimally invasive procedure or a larger incision can be used for an open surgery. In some situations, twoadjacent vertebrae30 can be distracted to open up theintervertebral space20. In some configurations, theexpandable interbody device300 can be used to at least partially distract the vertebrae during the implant procedure.
• A user can hold thehandle408 of thedeployment tool400 to implant theinterbody device300 in theintervertebral space20. Once theinterbody device300 is positioned between adjacent vertebrae, theactuation device420 can be rotated to turn thedrive426 and engage thescrew mechanism306. Thescrew mechanism306 changes length from a first length to a second length such that the proximalfrustoconical surface364 engages the upper proximal angled surface and the lower proximal angled surface, and the distalfrustoconical surface372 engages the upper distal angled surface and the lower distal angled surface to expand theupper structure302 and thelower structure304 from a first distance to a second distance.
• In some embodiments, materials such as fluids, medication, bone graft material, allograft and/or Demineralized Bone Matrix (DBM) can be delivered to the interior cavity of theinterbody device300. The material can be delivered through adelivery tube430 and into theproximal section350 of thescrew mechanism306 or through thearms402 of the deployment tool. In other embodiments, the material can be delivered through other paths to reach the cavity of theinterbody device300.
• To release theinterbody device300, thetranslation mechanism412 is rotated. Rotation motion of thetranslation mechanism412 is transferred to thesleeve410 as a linear motion away from thearms402 via the threaded connection. Thearms402 can move apart to release theinterbody device300 and allow removal of thedeployment tool400 from the patient.
• In some configurations, more than oneexpandable interbody device300 can be implanted between the adjacent vertebrae of the patient. In such embodiments, multiple expandableinterbody devices300 can be placed in a side-by-side configuration or any other suitable configuration, thereby creating additional support.
• In some embodiments of thedeployment tool400, the movement of thetranslation mechanism412 and/oractuation device420 can be effected by manual force applied by a person, such as by his or her hands, or alternatively it can be supplied or supplemented with a motor, pneumatics, hydraulics, springs, and/or magnetics. Some embodiments of the tool may comprise a squeeze handle for actuating the tool. Other embodiments of the tool can include closing mechanisms that include compound leverage, ratcheting, and/or multistep closing.
• Although certain embodiments, features, and examples have been described herein, it will be understood by those skilled in the art that many aspects of the methods and devices illustrated and described in the present disclosure may be differently combined and/or modified to form still further embodiments. For example, any one component of the device illustrated and described above can be used alone or with other components without departing from the spirit of the present disclosure. Additionally, it will be recognized that the methods described herein may be practiced in different sequences, and/or with additional devices as desired. Such alternative embodiments and/or uses of the methods and devices described above and obvious modifications and equivalents thereof are intended to be included within the scope of the present disclosure. Thus, it is intended that the scope of the present disclosure should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.

Claims (22)

What is claimed is:

1. An expandable interbody device for placement between adjacent vertebrae comprising:

an upper structure comprising an upper proximal angled surface and an upper distal angled surface;

a lower structure comprising a lower proximal angled surface and a lower distal angled surface, the lower structure configured to slideably couple with the upper structure; and

a screw mechanism between the upper structure and the lower structure, the screw mechanism comprising:

a proximal section comprising a proximal frustoconical surface;

a distal section comprising a distal frustoconical surface; and

a coupler comprising a proximal side configured to engage the proximal section and a distal side configured to engage the distal section;

wherein the proximal section and the distal section are configured to rotate as a unit to change a length of the screw mechanism from a first length to a second length;

wherein the proximal frustoconical surface is configured to engage the upper proximal angled surface and the lower proximal angled surface, and the distal frustoconical surface is configured to engage the upper distal angled surface and the lower distal angled surface to move the upper structure and the lower structure from a first distance to a second distance.

2. The device ofclaim 1, wherein the coupler further comprises at least one anti-rotational feature configured to engage the upper structure or lower structure to prevent the coupler from rotating when the proximal section and the distal section are rotated.

3. The device ofclaim 1, wherein the proximal section comprises first threads wound in a first direction configured to engage a proximal threaded hole in the coupler, and the distal section comprises second threads wound in a second direction, opposite the first direction, configured to engage a distal threaded hole in the coupler.

4. The device ofclaim 3, wherein the first threads and the second threads have an equal pitch, such that when the screw mechanism is actuated, a proximal end of the interbody device changes height at the same rate as a distal end of the interbody device.

5. The device ofclaim 3, wherein the first threads and the second threads have a different pitch, such that when the screw mechanism is actuated, a proximal end of the interbody device changes height at a different rate than a distal end of the interbody device.

6. The device ofclaim 1, wherein the upper structure and lower structure further comprise a plurality of protrusions or teeth.

7. The device ofclaim 1, wherein the upper structure and/or the lower structure comprise vertebrae engagement surfaces with a porous or roughened surface.

8. The device ofclaim 7, wherein the vertebrae engagement surfaces comprise a titanium coating.

9. The device ofclaim 1, wherein the proximal section comprises at least one hole in fluid communication with a drive interface and an interior cavity of the interbody device.

10. The device ofclaim 1, further comprising at least one recess configured to couple with a deployment tool, the at least one recess comprising a hole in fluid communication with an interior cavity of the interbody device.

11. The device ofclaim 1, wherein the distal section comprises a keyed shaft configured to slideably engage with a matching keyed bore on the proximal section.

12. An expandable interbody device for placement between adjacent vertebrae comprising:

an upper structure;

a lower structure configured to slideably couple with the upper structure; and

a screw mechanism between the upper structure and the lower structure, the screw mechanism comprising a proximal section and a distal section that are configured to rotate as a unit to change a length of the screw mechanism from a first length to a second length;

wherein the change in the length of the screw mechanism causes the distance between the upper structure and the lower structure to change from a first distance to a second distance to form a chamber to be filled by one or more of fluids, medication, bone graft material, allograft and Demineralized Bone Matrix.

13. A kit for performing spinal stabilization, the kit comprising:

an expandable interbody device for placement between adjacent vertebrae, wherein in an expanded configuration the expandable interbody device comprises a chamber; and

a deployment tool for delivering the expandable interbody device between adjacent vertebrae, the deployment tool comprising a distal portion that is releasably attachable to the expandable interbody device and a proximal portion configured to extend outside a surgical incision;

wherein the proximal portion comprises an opening to a channel that extends through the deployment tool and is in fluid communication with the distal portion of the deployment tool, the channel capable of transporting a material from outside the incision into the chamber of the expandable interbody device.

14. The kit ofclaim 13, wherein a proximal section of the expandable interbody device comprises at least one hole in fluid communication with the chamber.

15. The kit ofclaim 13, wherein the expandable interbody device further comprises at least one recess with a hole that is in fluid communication with the chamber.

16. The kit ofclaim 15, wherein the deployment tool comprises arms that are configured to attach to the at least one recess and further comprises one or more channels extending to the tips of the arms to deliver material through the at least one recess into the chamber of the expandable interbody device.

17. A method of implanting an expandable interbody device between adjacent vertebrae comprising:

positioning the expandable interbody device between adjacent vertebrae, wherein the expandable interbody device comprises:

an upper structure;

a lower structure configured to slideably couple with the upper structure; and

a screw mechanism between the upper structure and the lower structure;

rotating the screw mechanism to change a length of the screw mechanism from a first length to a second length which causes the distance between the upper structure and the lower structure to change from a first distance to a second distance to form a chamber; and

injecting material into the chamber.

18. The method ofclaim 17, wherein the first distance corresponds to a collapsed configuration with the upper structure adjacent the lower structure and the second distance corresponds to an expanded configuration with the upper structure separated from the lower structure.

19. The method ofclaim 17, wherein the screw mechanism comprises:

a proximal section comprising a proximal frustoconical surface;

a distal section comprising a distal frustoconical surface; and

a coupler comprising a proximal side configured to engage the proximal section and a distal side configured to engage the distal section.

20. The method ofclaim 17, wherein the material is one or more of fluids, medication, bone graft material, allograft and Demineralized Bone Matrix.

21. The method ofclaim 17, wherein the expandable interbody device is positioned between the adjacent vertebrae using a deployment tool that extends from the vertebrae to outside an incision.

22. The method ofclaim 21, wherein injecting the material comprises delivering the material through a channel extending through the deployment tool.

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